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HIDREX GMBH l Otto-Hahn-Str. 12 l D-42579 Heiligenhaus l Germany
User Manual
Tap Water Iontophoresis Systems
HIDREX® GS 400
HIDREX® PS 500
0197
Rev. 1.2; Sep. 9, 2007
Table of Contents
Table of Contents.....................................................................................................2
Read Before Use ......................................................................................................2
Your safety is important - Contraindications......................................................................3
Additional important safety considerations........................................................................3
Intended Use / Mechanism of Action ....................................................................4
Treatment Fundamentals ..................................................................................................5
System Components...............................................................................................6
Control Unit ........................................................................................................................6
Standard Accessories........................................................................................................6
Optional Accessories.........................................................................................................6
Controls on the Side Panel................................................................................................7
Controls on the Back Panel...............................................................................................7
Front Panel Controls..........................................................................................................8
Installation / Treatment Setup ................................................................................9
Setup for Treating Hands and Feet...................................................................................9
Setup for Axillary Treatment (Armpits) ........................................................................... 10
Treatment Setup for Special Applicators........................................................................ 10
Conducting Treatments ........................................................................................11
Primary Parameter Setup (Setup Mode)........................................................................ 11
Begin Treatment (Treatment Mode)............................................................................... 13
Important Advise for Conducting Treatments ................................................................ 16
Side Effects..................................................................................................................... 16
General Information...............................................................................................17
Special Remark............................................................................................................... 17
Care and Maintenance ................................................................................................... 17
Symbol Legend............................................................................................................... 18
Error Checklist................................................................................................................. 18
Operational Check.......................................................................................................... 19
Shipping the Device for Repair or Maintenance ............................................................ 19
Applicable Regulations and Legal Requirements.............................................19
Technical Safety Inspection............................................................................................ 20
Waste disposal of package and Electro Garbage.......................................................... 20
Reconditioning and Disinfection ..................................................................................... 20
Lifespan........................................................................................................................... 21
Electric-Magnetic Compatibility ...................................................................................... 21
Broadputlines and Manufacturer-Declaration ................................................................ 21
Technical Data........................................................................................................24
Manufacturing and Distribution....................................................................................... 24
Read Before Use
Your HIDREX iontophoresis device was designed to maximize functionality
and usability. System setup is easy and the device is simple to operate. This
manual is intended to guide you through the setup procedure, familiarize
you with the system’
s features, and will offer hints on the use of your new
therapy system.
Your safety is important - Contraindications
Important:
Under no circumstances should you use iontophoresis if any of the
following conditions apply:
i
i
i
i
i
i
i
Patient with a cardiac pacemaker
Patient with an ICD (implantable cardioverter/defibrillator)
Pregnancy
Patient with a metal-containing intrauterine device (IUD)
Metallic implants within the current path (arm or leg)
Large skin defects / wounds that cannot be covered with petrolatum
Patients with impaired sensibility in their hands or feet (e.g. patients
with polyneuropathies)
Warning:
i The treatment system may only be powered by the HIDREX wall
adapter (to recognize at HIDREX nameplate with Serial-No.). This
power supply is especially designed for this device.
i In order to prevent burns during treatment, make sure the supplied
towels cover the treatment electrodes at all times. Avoid direct contact
with the metallic surface.
i Two devices may not be simultaneously used by one patient.
i Prior to treatment, remove any metallic jewellery (wedding bands etc.)
which would otherwise be immersed in the water bath. Keeping such
accessories on would lead to localized minor (electrical) burns
secondary to increased current densities.
Additional important safety considerations
Ö Place the treatment device on a firm level surface.
Ö Make sure that the treatment device is at room temperature before
you power it up.
Ö You may remove your hands or feet from the treatment water bath at
any time, but it is advisable to lower the dose to zero before you do
so. In rare cases, uncomfortable electric shocks1 may result if the
dose is not reduced.
1
These electric shocks are definitely uncomfortable, but absolutely harmless.
-3-
Ö The system may not be operated in the vicinity of shortwave or
microwave medical diathermy devices. A minimum distance of 2
meters should be kept at all times.
Ö Prior to using wall power, check that your outlet power meets the
system’
s requirements of 110-230 V~ and 50-60 Hz.
Ö Unplug the wall power adapter if a thunderstorm approaches or if you
do not intend to use the treatment system for an extended period of
time.
Ö This treatment device may only be used indoors. Do not expose the
system to rain or excessive moisture.
Ö Prior to cleaning the system, turn the device off and unplug all
connectors. For cleaning, use a soft cloth moistened with a mild
cleaning agent.
Ö Do not use kerosene, thinner, alcohol, wax remover or any other
solvents.
Ö Prevent kinking of the cable and do not expose the cable to heat or
chemicals. If the cable is damaged, unplug it from the device and
have it checked by the HIDREX Company.
Ö Never open the device; there are no control elements inside. The
system may only be serviced by the HIDREX Company.
Ö Wash the supplied towels on a regular basis together with your
regular laundry (make sure to comply with the laundry instructions on
the tag).
Intended Use / Mechanism of Action
During HIDREX treatment, a current flows through the body regions
under treatment. The water bath mediates this current flow. The skin
areas inside the treatment water will thereby secrete less sweat.
Although treatment success has been validated in numerous medical
studies, there is still no completely satisfactory scientific explanation for
the mechanism of action. Medical researchers believe that the electrical
current irritates the synapses between sweat-inducing nerves and sweat
glands to such an extent that sweat glands can no longer be stimulated.
In other words: The treatment does not affect the sweat glands directly, it
only affects the nervous input to these glands.
This effect explains why the original condition returns relatively
quickly when the treatment is discontinued!
-4-
The treatment current can be adjusted according to your individual
sensitivity. There is no risk involved as the current cannot exceed certain
maximum values.
Remark: In general, HIDREX treatment results do not depend on the
direction of current flow. The anode (red), however, is slightly
more effective than the cathode (black). Current direction
should therefore be reversed on a regular basis – but not
within one treatment session.
Important: The HIDREX iontophoresis units GS 400 and PS 500 are
intended to treat hyperhidrosis affecting hands, feet, face,
necks / back and arm pits. Any other use or usage beyond
this scope is considered unintended use and may have
dangerous consequences.
Treatment Fundamentals
HIDREX iontophoresis devices are primarily intended for treating
hyperhidrosis1 (excessive sweating) of hands and/or feet. Provided the
optional axillary applicators are utilized, the system can also be used for
treating axillary hyperhidrosis.
The HIDREX treatment concept comprises two treatment phases:
Phase 1: The initial phase (therapy initiation) is conducted under a doctor‘
s
supervision. During this stage, patients learn to administer
treatments. For therapy initiation, three weekly treatments of
approximately 15 minutes each should be scheduled (not more
than one treatment per day). Sweat secretion will normalize after
approximately 10 treatments.
Phase 2: Long term treatment (maintenance therapy) is indicated because
the HIDREX treatment effect is reversible. Patients should
conduct maintenance therapy sessions by themselves at home
and with their own unit. Depending on the severity of the
condition, maintenance therapy involves one to three weekly
sessions of approximately 15 minutes each.
1
Additional indications include: Dyshidrotic dermatitis, palmoplantar pustolosis and
acrocynosis.
-5-
System Components
Your HIDREX therapy system comprises a control unit and the accessories
explained in the following chapters.
Control Unit
Model
PS 500
Model GS 400
Standard Accessories
ç
æ
å
ä
è
Hard Shell Case
(Kofferschaleä)
å Treatment electrode
æ Towel
ç Dual connecting cable set
è Safety wall adapter
Optional Accessories
é
é Ergonomic treatment
tray
ê Axillary applicators
(Set AX I or AX II)
-6-
ê
ë Face mask
ì Nape or back applicator (not depicted)
í Set DUO (not depicted)
includes 2 additional electrodes each, towels, and
a dedicated cable set (allows simultaneous
treatment of hands and feet)
ë
Also refer to chapter “Treatment Setup und
installation”.
Two types of axillary applicators ê are available: a pair of sponge cushions
with leather covers and a pair of sponge pouches with special small
electrodes (AX electrodes).
The special applicators ì are made of foam and come equipped with hook
and loop tapes. These applicators are also used with the AX electrodes.
Controls on the Side Panel
jswitch)
j Therapy system main ON/OFF switch (main power
Controls on the Back Panel
12V DC
+
m
k
k Jacks for connecting the dual connecting cable set (treatment electrodes)
m Connector for safety wall adapter (12V DC)
-7-
Front Panel Controls
z
3 LEDs
indicating
selected user
u Main Display
{ LED:
Sensitive
mode active
| LED: Pulsed
current active
} LED:
Immersion
monitoring
y Pushbutton
(increase time /
select user)
~
w Pushbutton
x Pushbutton
(decrease time /
select sensitive
mode)
LED: Memory
function active
(increase
dose / select
type of
current)
v Pushbutton
(lower dose /
confirm primary
settings)
uMain Display
} LED:
Immersion
monitoring
v Pushbutton
y Pushbutton
(increase time /
memory
function)
x Pushbutton
w Pushbutton
(decrease time)
-8-
(increase dose)
(lower dose /
confirm primary
settings)
Installation / Treatment Setup
The following steps describe how you set up your therapy system for a
treatment session. Please note that the setup for treating hands or feet is
slightly different from the setup required for treating hands and feet
simultaneously and for treating the armpits.
Setup for Treating Hands and Feet
1) Place the therapy device on a firm, level surface. Make sure an electric
outlet is within reach.
2) Insert the safety wall adapter cable è into jack m on the rear panel and
plug the adapter into a wall outlet.
3) Plug the color-coded connectors of the dual cable set ç into the jacks
k on the back panel, matching colors.
4) Push the red and black terminals of the dual connecting cable set ç
firmly onto the respective connectors on the treatment electrodes å.
Make absolutely sure to forcefully push the connectors all the way
onto the necks of the treatment electrodes.
5) For simultaneous treatment of hands and feet, use the optional DUO
accessory set and the hard shell cases ä for your feet and the
ergonomic blue treatment trays éfor your hands. Connect the two
electrodes in the hard shell cases and the electrodes in the treatment
trays each to the respective cables from the DUO set. Now connect the
black and red connecting cable ç with one electrode of the hard shell
case and one electrode of the treatment tray.
6) Place one treatment electrode å in each hard shell caseä, or in each
treatment tray é, respectively. When using the ergonomic treatment
trays é, make sure the sloping rims point toward yourself (drainage
groove away from you) – this will facilitate hand immersion.
7) Completely cover all treatment electrodes å with a towel æ each.
8) Now fill both hard shell cases and/or treatment trays with hand warm tap
water so that the skin areas to be treated can be easily immersed (the
backs of the hands and backs of the feet should not be covered with
water!).
-9-
Setup for Axillary Treatment (Armpits)
The setup for axillary treatment is mostly identical to the setup for hand
or feet treatment, although axillary treatment requires special axillary
applicators êinstead of water baths (trays).
î
î
ï
ï
ê Axillary applicators
ç
1) Proceed with steps 1 to 3 of the instructions on the previous page.
2) Firmly push both plugs of the dual connecting cable ç onto the jacks
of the AX electrodes ï.
3) Thoroughly soak the sponge cushions (AX I) equipped with integral
leather pouches or the sponge pouches (AX II) î with hand warm
tap water. At this time, insert the AX electrodes ï (Do not squeeze
any water from the sponge cushions or sponge pouches.).
Treatment Setup for Special Applicators
The AX electrodes ï are also used for conducting treatments with the face
mask ë or the nape or back applicator ì. Treatment setup is identical to
the setup for axillary treatments except for the requirement to insert the AX
electrodes ï into the pouches sewn onto the respective applicators.
Please ascertain that the sponge material is completely soaked (do not
squeeze). Now secure the applicator with the hook and loop fasteners.
- 10 -
Conducting Treatments
Please observe the following two items before you begin a treatment
session:
1) When conducting a treatment, avoid removing your hands or feet
from the water bath or removing the axillary applicators from your
armpits. If you ignore this advice, you run a slight risk of feeling a
completely harmless – yet quite uncomfortable – electric shock. This
shock may occur although the HIDREX system comes equipped with
a protection circuit designed to permit current flow interruption.
2) Before you start a treatment session and close the current path with
your armpits, hands, or feet, make sure to first turn on the main
power switch j. If this sequence is reversed, there is also a chance
that you receive a completely harmless – yet quite uncomfortable –
electric shock!
Primary Parameter Setup (Setup Mode)
Depending on the specific HIDREX system you own, you can choose
between various options before you initiate a treatment. How you select
and store these parameters is described in the following paragraphs.
1) After setting up your HIDREX therapy system in accordance with the
instructions in the “Installation” chapter, turn on the control unit by
pushing the main power switch j. First, the main display Πwill
briefly show three moving bars. Next, the following text is shown for
about 8 seconds:
Setup Mode indication
Various treatment options can be selected as long as this text
remains visible.
Important: If no button is pressed within approximately 8 seconds,
the device will automatically switch from setup to
treatment mode.
Hint: By pressing the ENTER key •, you can directly switch to
treatment mode without having to wait.
- 11 -
2) Once in Setup Mode, activate or deactivate the options as desired1:
Option
Model
Function
Memory
GS 400
If Memory is activated, Active if LED • is lit
the unit will always save
the most recent “time“and
“dose” treatment settings;
otherwise the system runs
in manual mode.
In addition to the primary
Active if LED ‘ is lit
settings (pulse and
sense), the unit saves the
“time”and “dose”treatment parameters for 3
users. If no LED is lit, the
unit is in manual mode.
Key •
USER
PS 500
Key •
Symbol
(User change by pressing the
button several times.)
SENSE
PS 500
When SENSE is active, Active if LED ’ is lit
decreased setting apply to
power output, maximum
current, and current slope.
This function was designed
for
sensitve
patients, children, and for
treating armpits and face.
PS 500
When PULSE is active, a Active if LED “ is lit
pulsatile treatment current
is used. PULSE minimizes
the uncomfortable tingling
sensation when current is
flowing.
Key •
PULSE
Key Ž
Important: The Setup Mode is generally activated only direct after
switching on the device. If you left the Setup mode, you
must turn off the device shortly and then again, must switch
on in order to alter the above treatment options.
1
Adjust the system in accordance with your doctor’
s instructions.
- 12 -
Begin Treatment (Treatment Mode)
After completion of the initial setup, the unit will automatically switch to
treatment mode after about 8 seconds or when the ENTER button • is
pressed. Depending on user selection or memory function, the intended
treatment time and dose will be displayed. Before you start the actual
treatment session, you need to check and/or set the “time”and “dose”
treatment parameters.
1) Setting treatment parameters:
If you have deactivated the memory function (LED • is not lit) or if no
user has been selected (none of the three LEDs ‘ is lit), the main
display will show the following:
On the left, the display indicates the
scheduled treatment duration in
minutes, and on the right, the preselected treatment dose in Volts.
The colon blinks during this phase!
Select the desired treatment dose1 with buttons • and Ž, and the
desired treatment duration with buttons • and •. Each time you push
one of these buttons, the corresponding treatment parameter is
increased or decreased by one Volt or one minute, respectively.
Hint: By holding one of the push buttons down, you can continuously in- or
decrease the corresponding treatment parameter.
Special functions MEMO, respectively HAND, FOOT, AXE
If the memory function is active or
when a user has been selected, the
device proposes the corresponding
saved treatment parameters (time
and dose). You can adjust these to
your needs by pushing the
respective buttons.
The system saves these settings. When another treatment session is
started, the device will automatically suggest the latest settings.
If you adjust treatment parameters during a treatment session, the
system will automatically save these changes as well.
1
Select the dose in accordance with your doctor’
s orders or use the table of factorypreset treatment parameters for guidance (see page 14 in this manual).
- 13 -
Hint: In addition to storing HAND, FOOT, and AXE for each user, model
PS 500 also saves the respective treatment dose and time plus
the selected primary settings SENSE and PULSE. These are the
settings the device will propose when a new treatment session
begins.
In the factory, your HIDREX system is preset as follows:
Option
Gerät
Behandlungsparameter
Memory
GS 400 SENSE:
PULSE:
DOSIS:
ZEIT:
not available
not available
0 Volt
15 minutes
HAND
PS 500
SENSE:
PULSE:
DOSIS:
ZEIT:
deactivated
activated
20 Volt
15 minutes
FOOT
PS 500
SENSE:
PULSE:
DOSIS:
ZEIT:
deactivated
deactivated
30 Volt
15 minutes
Axe
PS 500
SENSE:
PULSE:
DOSIS:
ZEIT:
activated
activated
18 Volt
15 minutes
The settings provided in the table above are also the recommended
initial values for treating in manual mode.
In order to avoid skin irritation by excessive dose settings in pulsed
mode (where current flow is nearly completely imperceptible), we
recommend that you assess your individual direct current
thresholds for hands, feet, or armpits before you start the first
treatment session. To conduct axillary treatments, the dose should
not be raised above 15, not even in SENSE mode, because the
sensitive skin may otherwise get burnt.
2) Treatment start:
When treating hands or feet, place only one hand or foot onto the towels
æ laying in the tap water filled hard shell cases (Kofferschalenä) or
treatment trays é. Make sure that your skin does not touch the
electrodes directly. Do not forget to remove any jewellery!
- 14 -
To conduct an axillary treatment, pack the soaked axillary applicators ê
into your armpits. Make sure the applicators fit well and apply even
pressure to maximize the contact area in your armpit. The well soaked
face mask and special applicators are secured with hook and loop
fasteners.
When the integral “immersion monitoring” system
recognizes that the circuit is closed, the Dive-LED
” lights up to indicate that treatment has started.
The colon expires during the Treatment!
On the display, the dose setting changes
from the desired setting to zero, before it
slowly increases to the desired value.
3) Adjusting treatment parameters:
At any time throughout the treatment session, you can change treatment
time and dose settings by pressing the respective push buttons.
Important: If you perceive very localized pain during a treatment, you
need to interrupt the session and cover the painful area with
petrolatum. By pressing an arbitrary button, the automatic
rising of the treatment dose can be interrupted.
If you interrupt the treatment by removing your hands or feet from the
bath, the Dive-LED ” goes off and the treatment timer is halted. The
display shows the remaining treatment time and the selected dose.
When you continue the treatment, the Dive-LED ” will light up again and
the dose display changes to zero, before it slowly increases to the
desired value.
Hint: You can use your fingers to operate the controls even if your hands
are inside the hard shell cases. To accomplish this, the device needs
to be positioned directly in front of one of the hard shell cases. Make
sure that the palm of the hand you intend to operate the controls with
stays under water and on the towel, so that the current path remains
closed. After dose adjustment, pull the entire hand into the water
bath, making sure palm and towel remain in contact at all times.
4) Ending a treatment session:
When the treatment time is up, the treatment dose is automatically
lowered to zero. Please keep your hands and feet in the water bath (or
the axillary applicators in place, respectively) until the dose display reads
“End“. Switch the device off.
- 15 -
Important Advise for Conducting Treatments
For your safety, your HIDREX treatment system comes equipped with
several protective circuits.
Immersion monitoring
Until the treatment current path is closed (immersion monitoring) by
immersion of the palms, the dose cannot be increased to any value
above zero. The Dive-LED ” will light up when immersion is complete.
Over-treatment protection
If your skin is dryer than normal 1, the dose cannot be increased
(protection against over-treatment). Your HIDREX system automatically
checks your specific skin conductance. If your skin conductance is
beyond the preset threshold, the protection circuit is activated and locks
the system. The Dive-LED ” does not light up, even when the treatment
current path is closed.
Hint: To double-check if over-treatment protection has been activated for
you, simply ask another person to close the current path (this can be
done without starting an actual treatment). If the Dive-LED ” lights
up when the other person closes the current path, the system is in
good working order.
If over-treatment protection is activated, you should interrupt your
treatment course for at least one week until excessive perspiration
returns.
Please contact us if the over-treatment circuit triggers although you still
have excessive perspiration, a situation that may arise in rare
circumstances. In that case, we would readjust the sensitivity settings to
your needs.
Side Effects
Mild dysesthesia (tingling or burning) can occur under therapy, as well as
short-term skin irritation (reddening) after treatment.
Important: Make absolutely sure to pay attention to the list of
contraindications! Excessive dose settings can lead to burns!
1
This does not relate to the water bath, but to the moisture content of the deeper skin
layers, an indicator of the extent of hyperhidrosis.
- 16 -
General Information
This chapter contains important instructions about your HIDREX system.
Special Remark
Our responsibility for system safety, functionality, and reliability applies
only if any maintenance and servicing is exclusively performed by
ourselves or by personnel authorized by us. Our warrantee ceases and
we assume no liability if any manipulation or service is performed by
unauthorized personnel.
Care and Maintenance
HIDREX iontophoresis systems are basically maintenance-free. To prevent
calcium deposits on the sheet metal, please make absolutely sure to
remove any moisture from the treatment electrodes after each treatment.
The control unit, treatment trays, and electrodes should be cleaned with a
moistened cloth or with a common detergent. Surface disinfectants may
also be used.
The AX sponge cushions can be washed at 90°C; alternatively, they may be
steam-sterilized or immersed in a disinfectant solution. If disinfectant is
used, the sponges should be thoroughly rinsed with water before they are
reused. The towels can be washed in the washer with your regular laundry - follow the specific instructions. Common disinfectant supplements for
laundry detergents may be used.
Calcium deposits on the electrodes can impair current flow. Use a
household calcium deposit remover or immerse the electrodes in vinegar.
Expect discoloration of the electrode metal after the first therapy sessions.
Warning: Before cleaning, make sure the device is turned off and
separated from the power line. Never use kerosene, thinner, or
other solvents.
*
Henkel: Incidin Extra (1%), Incidin Plus (0.5%), Incidur (0.5%), Minutil (0.5%)
Dr. Trippen (desomed): Biguamed
B. Braun: Melesept SF (0.5%/5%), Hexaquart S (1.5%/5%), Meliseptol (undiluted)
- 17 -
Symbol Legend
Connector for treatment electrodes
+ = Anode
(red cable)
− Cathode
=
(black cable)
0197
Type BF1 device
Device identification: Serial-No.: yy-x.x zzz
yy:
x.x:
zzz:
Year of manufacture
internal product type ID
consecutive number
Error Checklist
If prior to, during, or after a treatment session, the device does not
operate in accordance with this manual, please go through the following
checklist before you send the device for repair. Working through the
checklist as the first step can save you considerable cost and
inconvenience. Thank you.
Ö Verify that the safety wall adapter is properly connected to the
control unit and to the wall outlet.
Ö Verify that the connectors on the dual connector cables are pushed
far enough onto the receptacles of the treatment electrodes for
establishing a reliable connection.
Ö The dose will only be increased to the selected setting after the time
display shows a value of greater than 1 minute and the skin has
closed the treatment current path (Dive-LED ” is lit).
Ö Verify that the device works properly on another person (overtreatment protection).
Ö Complete the operational check described below.
Hint: In rare cases, tap water conductance may be inadequate (e.g.
when tap water deionizing equipment is in use). If that case, try
non-carbonated mineral or table water instead.
1
Device leakage currents comply with standards -- the system provides protection
against electrical shock (Type B); device is insulated (floating) (Type F).
- 18 -
Operational Check
Proceed with the following steps for an operational check of your HIDREX
system:
1) Set up the therapy system as you would for a treatment.
2) Activate the main power switch j to turn the control unit ON. Dose
and treatment time settings should appear on the main display Œ.
3) Now close the treatment current path by placing one electrode onto the
towel that covers the other electrode, but do not let the electrodes touch.
Both electrodes a now immersed in a water-filled tray and lie on top of
each other, remaining separated by a towel. When testing the system
with AX electrodes, directly press both water-soaked sponge cushions
together.
4) The unit’
s Dive-LED ” should now be lit and the dose should rise to the
preset value.
If the dose does not increase under this test although the items on the
error checklist have been followed, or if dose selection fails, please
contact us so that we can coordinate the required steps.
Shipping the Device for Repair or Maintenance
The device should only be shipped in the supplied carrying case. If at all
possible, use the original packaging material for shipping. Make sure the
device is protected against impact inside the case and that packaging is
suitable for shipping.
Prior to shipping, do not forget to clean and dry the system and the
accessories. Please do not ship towels, sponge cushions, or the facial
mask.
Please send all electrical accessories (safety wall adapter, treatment and
AX electrodes, and dual connecting cable set) together with the HIDREX
control unit.
Applicable Regulations and Legal Requirements
In accordance with addendum I and II of the MPBetreibV [Medical Device Vigilance
System] , the operator of a medical device is required to maintain a Medical Device Log
and to document completion of the safety inspections listed below.
Important:
Private persons who use the device only privately do not have to comply
with these requirements. Nevertheless, we recommend periodic safety
inspections in accordance with the regulations.
- 19 -
Technical Safety Inspection
Only competent technicians trained by the HIDREX GmbH may be contracted for
technical safety inspections. Suitable measuring and test equipment is mandatory. The
medical device may only be operated with the accessories listed in the instruction
manual.
In accordance with “MPBetreibV”, HIDREX iontophoresis units require technical safety
inspections every 2 years in addition to inspections after each repair or reconditioning.
Technical safety inspections have to cover at least the following items:
•
•
•
•
Visual check of medical device and accessories
Protective conductor test in accordance with DIN EN 60601-1:1990
Leakage current test in accordance with EN 60601-1:1990
Operational check of the medical device in accordance with the instruction manual
The operator is responsible to rectify any faults detected during the technical safety
inspections (i.e. the user has to make arrangements for repair).
Waste disposal of package and Electro Garbage
Our packages and the transportation-protection-parts were produced out
of non-polluting, salvageable materials. The form parts are from PS
(foamed, Polystyrol free of FCKW), foils and bags are from PE
(Polyäthylen) and outside-package are of cardboard. Dispose all
package-parts in an environmentally acceptable way.
If the appliance can become use no more, you please dispose expertly
of it. In the remainder, the national ordinances are to be heeded.
Appliances that are marked with the marginal symbol cannot be
disposed with the house-garbage. You are indebted to dispose of
such electro and electronics-garbage separately. Please inform
yourself about the possibility of the regular waste disposal with your
commune. With the separate waste disposal, you supply the garbage
to the recycling. You help to avoid with it that incriminating materials
reach into the environment (ElektroG).
Reconditioning and Disinfection
HIDREX iontophoresis systems are reusable medical devices; reconditioning is classified
as “non-critical”. The applicable joint recommendations of the “Kommission für
Krankenhaushygiene und Infektionsprävention am Robert-Koch-Institut (RKI) [RobertKoch Institute Division of Applied Infection and Hospital Hygiene]”and the “Bundesinstitut
für Arzneimittel und Medizinprodukte (BfArM) [Federal Institute for Drugs and Medical
Devices]” on “Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten
[Reconditioning of Medical Devices: Hygiene Requirements]”, published on August 25,
2001, need to be complied with.
- 20 -
For reconditioning, the device has to be cleaned and disinfected in accordance with the
instructions provided in the chapter on “Care and Maintenance”. The accessories towels,
treatment electrodes, and treatment trays (carrying case) need to be disposed of and
have to be replaced by new ones. In addition, a technical safety inspection has to be
completed and documented. The medical device may be reconditioned up to 10 times.
Lifespan
Legal reasons limit the lifespan of this medical device to 4 years. The manufacturer has to
recondition the medical device not later than by the end of this term. Each successful
reconditioning by the manufacturer extends the lifespan of the medical device by 2 years.
If the HIDREX iontophoresis system is reconditioned for the same patient, the treatment
trays or carrying case (depending on their condition) do not necessarily have to be
replaced.
Electric-Magnetic Compatibility
Of course, the HIDREX Devices are developed after the stipulated guidelines for
electromagnetic compatibility (EMV) and been manufactured.
Caution:
Medical-Electric-Appliances are subject to medical-electric-appliances. The
EMV particular precautions and must install in accordance with the EMVHints contained in the accompanying-papers and in operation is taken.
Wearable and mobile HF-Communication facilities, as portable phones or
Pager, can influence medical-electric-appliances!
Broadputlines and Manufacturer-Declaration
The following tables include the broad outlines and manufacturer-explanations after DIN
EN 60601-1-2:2001 of all magnet-field-therapy-appliances of the company Hidrex GmbH,
Otto-Hahn-Str. 12, D-42579 Heiligenhaus.
ELECTROMAGNETIC RADIATIONS DIN EN 60601-1-2, 6.8.3.201, Table 201
The Therapy-Appliances of the company Hidrex GmbH is certain for the business in the below stated electromagnetic
surroundings. The user of the respective appliance should guarantee that it is used in such a surrounding.
Emission- measurement
Conformity
HF- Emission
after CISPR 11
Group 1
HF- Emission after CISPR 11
Class B
Overtone after
IEC 61000-3-2
Class A
Voltage swing/ patcher after IEC 61000-3-3
Comply
Electromagnetic environment - broad outlines
The appliance uses high frequency-energy
exclusively for his/its internal function. His/its HF
therefore is - end-program very low, and it is
unlikely that neighbouring electronic appliances are
disturbed.
The appliance is for the use in all facilities including
residential-areas and such certain that is
connected directly at a public supply-net, which
looks after also buildings that are used for
residential-purposes.
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RECOMMEND DEFENCE DISTANCE BETWEEN ACCEPTABLE AND MOBILE
HF- TELE COMMUNICATION DEVICE AND THERAPY DEVICE OF THE COMPANY HIDREX GMBH
DIN EN 60601-1-2, 6.8.3.201, Table 206
The device is meant for the business in a electromagnetic surrounding, where are HF- sturgeon sizes are controlled. The user
of the device can help due the fact, to avoid electric magnetic disturbulece, by keeping the minimum distance between
acceptable and mobile HF- Tele communication device (transmitter) and the device – dependent on the power output of the
Communication device, like specified below.
Defence distance, dependent on the transmit frequency in m
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2,5 GHz
Wattage rating of the
transmitter W
d={ 3,5/V1 }√P
d={ 3,5/E1}√P
d={ 7/E1 }√P
0,01
0,12
0,12
0,23
0,1
0,37
0,37
0,74
1
1,17
1,17
2,33
10
3,70
3,70
7,37
100
11,70
11,70
23,33
For transmitters, that maximum wattage rating is not specified in table above, the advice defence distance d can be
ascertained in meters (m) under disposition of the equation, that belongs to the respectively chasm, which according the
specification of the transmitter producer, the maximum wattage rating of the Transmitter in watt (W) is P.
NOTE 1: The higher frequency-area near 80 MHz and 800 MHz is valid .
NOTE 2:
These broad outlines may not be applicable in all cases. The spread of electromagnetic sizes is influenced by
absorptions and reflections of the buildings, objects and people.
ELECTROMAGNETIC STABILITY
DIN EN 60601-1-2, 6.8.3.201, table 202
Electromagnetic
environment-broad
outlines
Floors should consist of
wood or concrete or with
ceramics-flow is equipped.
If the floor with synthetic
material is equipped, the
relative humidity must
amount at least 30
percent.
Stability verification
IEC 60601Verification gauge
Conformity
gauge
Discharge static Electricity(ESD) after IEC 61000-4-2
± 6 kV Contactdischarge
± 8 kV
Air discharge
± 6 kV
± 8 kV
Fast transient electric sturgeon-sizes / Bursts of
IEC 61000-4-4
± 2 kV for main
connection
± 1 kV für
in and
out connection
Not applicable
-----------------± 1 kV
The quality of the supplytension should correspond
to that of a typical business
or hospital-surroundings.
Withstanding (Surges)
after IEC 6100-4-5
± 1 kV scanningtension
± 2 kV
common mode
tension
± 1 kV
± 2 kV
The quality of the supplytension should correspond
to that of a typical business
or hospital-surroundings.
Tension-break-ins, shortly, in the time ofinterruptions and with fluctuations of the supply
voltage after IEC 61000-4-11
There was been by the power adapter the test. The power adapter has
an independent decrease.
Magnetic field at the supply frequency (50/60 Hz)
after IEC 61000-4-8
The device engendered a magnetic therapy field. Cancelled the
measuring.
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ELECTROMAGNETIC STURGEON-SOLIDITY
DIN EN 60601-1-2, 6.8.3.201, table 204
Sturgeon-strength test
IEC 60601test gauge
Accordance-levels
Elektromagnetic surroundings - broad outlines
Wearable and mobile radio equipments should
be used in no more inferior distance between
the appliances including the managements as
the recommended protection-distance that is
calculated after the equation applying to the
transmitting frequency.
recommended protection distance:
d={ 3,5/V1 }√P
d={ 3,5/E1 }√P for 80MHz to 800 MHz
HF led - sturgeon-sizes
after IEC 61000-4-6
Beamed HF - sturgeonsizes of IEC 61000-4-3
3 Veff
150 KHz to 80 Mhz
3 V/m
80 MHz to 2,5 GHz
V1 = 3 V
E1 = 3 V/m
d={ 7/E1}√P for 800 MHz to 2,5 GHz
with P as nominal-performance of the station in
watt (W) in accordance with statements of the
station-manufacturer and d as recommended
protection-distance in meters (m).
The field-strength of stationary radio-stations
should be more inferior than the accordancelevel with all frequencies in accordance with an
examination on the spot.
In the surroundings of appliances, that carries
the following picture-sign, disturbances are
possible:
NOTE 1: The higher frequency-area near 80 MHz and 800 MHz is valid .
NOTE 2: These broad outlines may not be applicable in all cases. The spread of electromagnetic sizes is influenced
by absorptions and reflections of the buildings, objects and people.
a.
The field-strength of stationary stations, like Z.B. Basis-stations of radio-telephones and mobile country-radio
equipments, amateur-radio-stations, AT THE, and FM, radio and TV stations cannot be predetermined exactly
theoretically. In order to determine the electromagnetic surroundings regarding the stationary stations, a study of the
location should be considered. If the measured field-strength in the location, at which the appliance is used, exceeds
the above accordance-levels, the appliance should be observed in order to prove the due functions. If uncommon
features are observed, additional measures can be necessary, like i.e. a changed alignment or another location of the
appliance.
b.
Over the frequency-area of 150 kHz of 80 MHz, the field-strength should be more inferior than 3 V/m.
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Technical Data
Control Unit GS 400 and PS 500
Display-Tolerance
Treatment Voltage (Dose) ± 2 V
Treatment Time ± 1 %
Dimensions
190 x 49 x 137 mm
Mass
(W x H x D)
0.5 kg
Power input
Input voltage:
Max. input current:
Input power:
Environmental temperature
12 V
500 mA
max. 6 VA
+10°C to +30°C
Direct current output
Treatment voltage 60 V= max.
Treatment current
35 mA max.(into a 1 kΩload)
Max. output power 225 mW
Pulsed current output
Treatment voltage 60 V= max.
Treatment current
35 mA max (into a 1 kΩload)
Pulse repetition frequency 9.9 kHz
See supplementary sheet for guidelines and factory declarations in accordance with DIN EN 60601-1-2:2001 (EMC).
Safety Wall Adapter (Typ: Egston P2xFMW3 6W)
Input
Input voltage 100-240 V~ / 50-60 Hz
Max. current 400 mA
Output
Nominal output voltage 12 V=
Output current max. 0,5 A
Max. output power 6 VA
Manufacturing and Distribution
Tel.: +49 (0)1805 / 98 11 00
Fax: +49 (0)1805 / 98 11 33
HIDREX GmbH
Biomedizinische Technik
Otto-Hahn-Str. 12
D-42579 Heiligenhaus
Internet: www.hidrex.com
Email: [email protected]
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